1. Field of the Invention
The present invention relates generally to fluid containment bags and, more specifically, to a disposable bag for collection and containment of human bodily fluids such as urine, feces, or bile via a catheter.
2. Description of the Related Art
Persons who have undergone a colostomy, ileostomy or other surgical procedure involving the digestive tract may use a bag connected via a catheter or other connecting device to the stoma for collecting the effluent. Similarly, incontinent persons may use a bag connected via a catheter to their urinary tracts. Such bags typically have a flattened, rectangular shape with an opening in the top edge for receiving the fluid. The bag may also include an opening with a controllable valve in the bottom edge for periodically draining the fluid that collects in the bag.
The bag may be secured to the person's leg and concealed beneath clothing while the person moves about or may be suspended from a support while the person sleeps. The bag may include straps for securing it to a person's leg. The straps are typically made of an elastomeric material and looped through slits near the top and bottom edges of the bag. The straps known in the art are uncomfortable because they tend to bind the wearer's skin or leg hair when they are adjusted during attachment and removal. Moreover, the straps are cumbersome to adjust when the person desires to remove the bag. The wearer may attach a tube to the drain valve and use it to direct the stream of draining fluid into a toilet for disposal.
Practitioners in the art have recognized several problems associated with bodily fluid collection bags. Fluid may slosh about in the bag and annoy or embarrass the wearer. In addition, fluid in the bag may backflow into the catheter, increasing the risk of infecting the wearer. Punctures as small as a pinhole can cause fluid to leak. Furthermore, odors can escape through the same path along which fluid can backflow or through a puncture. Even the plastic walls of certain bags are not sufficiently impermeable to odors to completely prevent their escape.
U.S. Pat. No. 4,179,367, issued to Barthell et al., describes a hydrophilic polymer in granular or powdered form that forms a stiff gel or semisolid when it mixes with a water-based fluid such as urine collected in a bag. Mixing the polymer with collected urine thus prevents it from sloshing. Perfumes may be mixed with the hydrophilic polymer to mask odors.
Gelling a bodily fluid as suggested by Barthell et al. necessarily precludes draining it from the bag. Such a bag could not be emptied and must be discarded when the polymer is exhausted. Such a bag would thus be disposable, in contrast to a conventional re-usable or drainable fluid collection bag. The need to remove and replace a disposable fluid collection bag would arise much more frequently than the need to remove and replace a drainable fluid collection bag. It would therefore be desirable to provide a means for allowing a wearer to quickly and easily remove and replace a disposable bag.
A fluid collection bag having a gellable polymer, as suggested by Barthell et al., would be as susceptible to the same backflow problem as a conventional drainable fluid collection bag. The gelled material has a curd-like consistency that is considerably more viscous than bodily fluids and thus does not slosh about. Nevertheless, the gelled material would be undesirably expelled from such a bag if the bag were upset or squeezed.
Practitioners in the art have developed drainable fluid collection bags that include a one-way valve at the intake opening to reduce backflow of collected fluids into the catheter if the bag is upset or squeezed. The one-way valve may consist of a pliable tube that extends into the bag from the intake opening. The tube has a flattened shape when empty of fluid because it has two opposing walls that meet along two seams. Fluid may enter the bag because its pressure spreads apart the opposing walls of the tube. Fluid that has thus collected in the bag closes the valve by exerting pressure on the external walls of the tube, thereby forcing them together. The tube remains closed until further fluid is introduced. This type of one-way valve is often called a "flutter valve." Examples of bodily fluid collection bags having flutter valves are disclosed in U.S. Pat. Nos. 2,883,985, issued to Evans, U.S. Pat. No. 3,331,421, issued to Lambert, U.S. Pat. No. 3,403,410, issued to Benzel, et al., and U.S. Pat. No. 4,581,763, issued to Olsen. The perimeters of the walls of a flutter valve may, in the closed position, define a rectangular or ribbon shape, such as those disclosed by Olsen and Evans, or a triangular or conical shape, such as those disclosed by Lambert and Benzel, et al. Flutter valves may reduce fluid backflow, but the sealing effect is rather poor and does not completely prevent backflow. Flutter valves may also allow gases and their associated odor to escape.
These problems and deficiencies are clearly felt in the art and are solved by the present invention in the manner described below.